Kornimate/medical-research-clean huggingface dataset:
evaluation of comfort in subjects with moderate dry eye disease

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. this study will be conducted in canada and australia.


Eligibility criteria:
key inclusion criteria: * able to understand and sign an information consent letter * willing and able to follow instructions and maintain the appointment schedule * has dry eye symptoms key exclusion criteria: * has suffered any ocular injury to either eye in the past 12 weeks * is pregnant or lactating at the time of enrollment other protocol-specified inclusion/exclusion criteria may apply.

Keywords: dry eye
study of a deformability parameter of red blood cell

Conditions: Drepanocytosis

Summary: sickle-cell disease is one of the most common severe monogenic disorders in the world, it results in the synthesis of abnormal hemoglobin (hbs) instead of hemoglobin a. when deoxygenated, the sickle haemoglobin (hbs) polymerizes inducing the sickling of red blood cells (rbcs) and leading to decreased deformability and increased fragility. therefore, sickle rbcs exhibit a reduced lifespan associated with intravascular hemolysis, hemolytic anemia and low tissue oxygenation. sickle rbcs, which exhibit abnormal adhesive properties to endothelial cells, can block the microcirculation, causing the occurrence of painful vaso-occlusive crisis (voc), acute chest syndrome (acs), acute and chronic organ damage (heart, lung, liver, spleen, kidney, bone...) and shortened life span. a preliminary study performed on rbc from sickle cell patients (hb ss) has shown an alteration of a parameter measuring the overall deformability of rbcs by evaluating the nature of their movement in a shear flow. this parameter is significantly lower in sickle cell patients in steady state compared to a population of healthy individuals. the parameter is also significantly lower in sickle cell patients during voc when compared to patient in steady state. the main objective of this study is to evaluate the performance of the method for measuring the deformability of rbcs on an experimental prototype. measurements will be performed on blood samples from subjects with a normal hemoglobin electrophoretic profile, from heterozygous carriers of sickle cell disease and from patients with sickle cell disease. samples from paediatric patients will also be tested to study any specificity in comparison to adult subjects.


Eligibility criteria:
inclusion criteria: * repeatability of ftt (mechanical marker of deformability) measurements exclusion criteria: * effect of ambient temperature on ftt measurements * effect of sample processing time on ftt measurements
a study of patients with her2-positive metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with her2-positive metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * signed informed consent document (unless the irb has granted a waiver of consent) * signed authorization for the use and disclosure of health information document * her2-positive breast cancer * initial diagnosis of metastatic (stage iv) breast cancer within 6 months prior to enrollment * availability of cancer-specific historical data points in the patient's medical records exclusion criteria: * there are no exclusion criteria for participation in this trial

Keywords: her2-positive metastatic breast cancer her2
dose-escalation study of imc-001 in subject with metastatic or locally-advanced solid tumors

Conditions: Solid Tumor; Metastasis; Locally Advanced

Summary: this is a phase 1, open-label, multiple-ascending dose study to investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of imc-001 in subjects with metastatic or locally-advanced solid tumors

imc-001 is a pd-l1 targeting, fully human monoclonal antibody. the purpose of this study is to determine safety and evaluate pk, pd and clinical activity of imc-001. multiple dose levels of imc-001 will be tested in subjects with metastatic or locally-advanced solid tumors. data from this study will also help determine the recommended phase 2 dose of imc-001.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form (icf). 2. adult (19 years or older). 3. histologically or cytologically proven metastatic or locally-advanced solid tumors exclusion criteria: 1. treatment with non-permitted drugs (within the past 28 days of screening), including but not limited to systemic immunosuppressive agents, any other investigational medicinal product (imp), anti-coagulant, or live vaccines. 2. any prior cancer immunotherapy 3. concurrent anticancer treatments

Keywords: imc-001
abscopal effect from the low-dose radiotherapy in polymetastatic cancer patients receiving stereotactic radiotherapy

Conditions: Neoplasms; Secondary Malignant Neoplasm

Summary: recently, md anderson cancer center reported the phase ii trial to investigate high-dose radiotherapy (hdrt, 20-70 gy) and low-dose radiotherapy (ldrt, 1-10 gy) for metastatic cancer patients who had undergone immunotherapy. hdrt or hdrt+ldrt was conducted in two respective groups and the treatment group was determined according to the disease status of participants, not randomization. immunotherapy was maintained in this clinical study. therefore, we aim to investigate this abscopal effect from adding ldrt to hdrt, irrespective of previous immunotherapy, in this multicenter, single-arm study.


Eligibility criteria:
inclusion criteria: * patients who can provide their written informed consent * age ≥19 years * patients with histologically confirmed primary solid (irrespective of the status of the primary tumor) * patients with ecog performance status 0-2 * patients planning stereotactic body radiotherapy (three fractions) for extracranial metastases * based on recist v1.1, patients with at least one extracranial measurable lesion other than sbrt lesions * patients with one or more measurable lesions, which are not suitable for sbrt or palliative radiotherapy and can be considered for ldrt (bone metastasis is not indicated for ldrt) * patients with hematologic function suitable for radiotherapy (absolute neutrophil count ≥1,500/mm\^3, hemoglobin ≥9 g/dl, platelet count ≥100,000/mm\^3) * patients with a life expectancy of 6 months or more according to the researcher's judgment exclusion criteria: * patients participating in other clinical studies that may affect the efficacy/safety of this clinical study * patients with brain metastasis * patients planning sbrt for all measurable lesions due to oligometastasis * patients with a history of radiotherapy for extracranial metastases within 3 months of the enrollment * patients unable to cooperate with stereotactic body radiotherapy * patients who are pregnant or planning to * patients with advanced or multiple malignancies requiring aggressive treatment (excluding skin cancers other than melanoma or intraepithelial cancer) * patients who have received systemic steroid therapy or immunosuppressive therapy within 2 weeks of enrollment - patients with an (e.g. allergic disease, radiation pneumonitis, etc.) (the use of steroids for preventive purposes is allowed (e.g., to prevent vomiting during chemotherapy)) active autoimmune disease requiring systemic treatment within the past 2 years, evidence of clinically severe autoimmune disease, or syndrome requiring systemic steroid or immunosuppressive therapy (patients who need intermittent use of bronchodilators, inhaled steroids, or topical steroid injections, hypothyroid patients on stable hormone replacement therapy, type 1 diabetes patients, or patients recovering from childhood asthma/atopic dermatitis are permitted) * patients with active infection requiring systemic treatment

Keywords: neoplasm metastasis
evaluation of rosiglitazone anti-inflammatory effect with fdg-pet imaging

Conditions: Lung Inflammation

Summary: the purpose of this research study is to gain understanding of the basic responses of the lung to inflammation and specifically if a certain medication can reduce the inflammation alone or in combination with another. inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. "acute lung injury" involves inflammation that is not specific to one area of the lung and is caused by any one of several conditions: infection, trauma, breathing toxic substances, etc. when lung injury is severe, not enough oxygen can get into the body; this can lead to the need for mechanical support of breathing (mechanical ventilation), problems with brain, heart or other organ function, and in some cases, death.


Eligibility criteria:
inclusion criteria: * healthy man or woman, any race or ethnicity, age 19 - 44 years old * screening fev1 and fvc \> 90% of predicted * screening oxygen saturation by pulse oximetry \>97% on room air * capable of lying still and supine within the pet/ct scanner for \~1.5 hours * capable of following instructions for breathing protocol during ct portion of pet/ct * able and willing to give informed consent * bmi \< 35 exclusion criteria: * pregnancy (confirmed by qualitative urine hcg pregnancy test) * lactation * active menstruation * history of cardiopulmonary disease * currently taking any prescription medications * history of tobacco use or illicit drug use within the past year * presence of implanted electronic medical device * enrollment in another research study of an investigational drug * known allergy to rosiglitazone or zileuton * known allergy to both trimethoprim/sulfamethoxazole and amoxicillin * known allergy to drugs routinely used during bronchoscopy * history of chronic active liver disease or acute liver disease within the past 3 months * sgot \>47 iu/l, sgpt \> 53 iu/l, or bilirubin \> 1.1 mg/dl * inability lie flat for 1.5 hours for pet/ct scans or follow breathing protocol instructions for the ct portion of the pet/ct * prior research-related radiation exposure within the past year such that participation in this study would result in exposures that exceed the limits as defined by the fda rdrc regulations (21 cfr 361.1).

Keywords: lung inflammation positron emission tomography fluorodeoxyglucose rosiglitazone zileuton lung anti-inflammatory therapy
intravenous lidocaine plus intratracheal dexmedetomidine on postoperative sore throat

Conditions: Dexmedetomidine; Lidocaine; Sore Throat

Summary: objective: the present study was to investigate the effect of intravenous lidocaine combined with intratracheal dexmedetomidine on postoperative sore throat in patients undergoing thyroid cancer surgery. methods: investigators enrolled 144 patients with american society of anesthesiologists (asa) physical status i and ii, aged 18-65 years, and scheduled for elective undergoing thyroid cancer surgery with general anesthesia. the participants were randomly assigned into four groups(n=36 each group): group l received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 ml) for surface anesthesia. group d received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 ml). group ld received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 ml). group c received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 ml) for surface anesthesia.the incidence and severity of postoperative sore throat were recorded in four groups at 1 h, 2 h, 6 h, 24 h and 48 h after operation.


Eligibility criteria:
inclusion criteria: * thyroid cancer surgery with asa grades i-ii * aged 18-65 years * the patient's communication is normal and they have a certain learning ability exclusion criteria: * severe respiratory and circulatory system diseases * there was bradycardia (hr \< 60 beats/minute) or atrioventricular block before the operation * nervous system disease * mental and psychological disorders * abnormal liver and kidney functions * pregnant and lactating women

Keywords: dexmedetomidine lidocaine thyroid surgery sore throat
observational clinical investigation of ekg diagnostic performance of the apple watch augmented with an ai algorithm

Conditions: Atrial Fibrillation

Summary: this observational prospective clinical investigation will evaluate the performance on an artificial intelligence (ai) solution interpreting ecg (electrocardiogram) collected from an apple watch (ai-aw) in the detection of atrial fibrillation (af)

each patient hospitalized for ablation or cardioversion and having given consent to participate in the clinical investigation will have ecg recordings by apple watch performed simultaneously with a 12d ecg measurement by a cardiologist before and/or after treatment, in accordance with the existing patient monitoring protocol. similarly, patients attending a rhythmology consultation or hospitalized in the cardiology department will have simultaneous ecg recordings with an apple watch during the scheduled routine 12d ecg recording.

Eligibility criteria:
inclusion criteria: * patient aged 22 or older, able and willing to participate in the study * patient admitted to hospital for ablation, cardioversion or cardiac electrophysiological exploration or who comes for regular rhythmology consultations or hospitalized in cardiology department * patient who has read the information note and has given his or her consent before any procedure related to the study * patient affiliated to social security exclusion criteria: * pregnant or breastfeeding women * patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device. * subject related to the investigator or any other staff member directly involved in the conduct of the study * patient incapable of giving consent, minor or adult patient protected by law
efficacy of integuseal for surgical skin preparation in patients undergoing total joint replacement

Conditions: Prosthetic Joint Infection; Surgical Skin Infection

Summary: this study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (integuseal) in addition to standard surgical skin preparation in patients undergoing total hip replacement (tha) or total knee replacement (tka). integuseal is supposed to lock down the skin bacteria and reduce skin infection and other problems. this study will investigate whether integuseal is effective in reducing persistent wound drainage when used in addition to standard surgical skin preparation for total hip arthroplasty (tha) or total knee replacement (tka).


Eligibility criteria:
inclusion criteria: 1. subjects who are able and willing to provide informed consent; 2. male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin. 3. subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol. 4. subjects undergoing elective tha or tka procedures. 5. subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination. exclusion criteria: 1. subjects undergoing revision, hemiarthroplasty, or bilateral tha or tka 2. subjects undergoing non-elective tha or tka procedures. 3. pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception. 4. subjects with known allergies to iodine and/or chlorhexidine
home-based tdcs for prevention of suicidal ideation

Conditions: Suicidal Ideation

Summary: risk for suicide is elevated in the period after discharge from hospital among adults with major affective disorder. the primary objective of this study is to investigate the feasibility of delivering tdcs sessions for high-risk patients for suicide at home in the days following discharge from an emergency department or inpatient unit. this is a single-center, randomized, sham-controlled, double-blind clinical study. we plan to assess up to 80 adult patients for eligibility over 12 months of which 20 will be enrolled and randomized. clinical assessments will be performed at baseline, post-treatment day 14 (14 days after the first tdcs session), and follow-up day 30 and 60 (30 and 60 days after the first tdcs session, respectively).


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * diagnosis of mood or bipolar disorder registered in the electronic hospital medical record * history of suicidal ideation and/or suicidal behavior at the time of admission registered in the electronic hospital medical record * absent of suicidal ideation at the time of enrollment (defined as questions 1 and 2 of the c-ssrs answered "no") * ability and willingness to provide information and permission to contact at least one person in the case of a need to contact them to promote subject safety or inability to reach the subject for follow-up * a living situation with access to a private space suitable for the administration of the rs-tdcs sessions in the next three weeks * agree to use a medically acceptable form of birth control while receiving the treatment if you are an individual able to become pregnant * living in monroe county region, as this is the area covered by the mobile crisis team, a urmc psychiatric emergency team serving anyone within monroe county * device or computer with internet access for a urmc-approved remote rs-tdcs supervision * ability to manage proper use of the device in a practice session exclusion criteria: * acute psychiatric instability or substance abuse (e.g., psychotic symptoms, alcohol misuse in the previous three months, use of any illicit drugs in the previous three months) * unstable medical condition with reduction of functional capacity * history of epilepsy or seizures in the last year * history of neurodegenerative diseases registered in the electronic hospital medical record * presence of or implanted any ferromagnetic metal in the head or the neck * pregnant or breastfeeding or willingness to become pregnant in the next month * history of head trauma (e.g., head injury, brain injury) or neurosurgery * history of skin disorder or sensitive skin area near stimulation locations * the presence of pacemaker * current treatment with electroconvulsive therapy or transcranial magnetic stimulation
study to evaluate the efficacy, safety and immunogenicity of subcutaneous hx575 in the treatment of anemia associated with chronic kidney disease (sweep)

Conditions: Anemia; Chronic Renal Insufficiency

Summary: this is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 ckd subjects suffering from anemia and treated previously with a stable dose of esa s.c. correction of anemia will be maintained by s.c. administration of hx575 in two frequencies (i.e. qw and q2w), in order to maintain an hb target range of 10.0-12.0 g/dl.


Eligibility criteria:
inclusion criteria: * male and female ckd subjects with or without dialysis treatment * age \> 18 years * subjects under documented stable maintenance therapy with esa, s.c. at least once per week and in accordance with the relevant smpc, for at least 3 months with a total weekly dose of ≤ 300 iu/kg/week * subjects with controlled symptomatic anemia, defined as mean hb level between 10.0 g/dl and 12.0 g/dl, based on four hb measurements during the four-week baseline period * adequate iron status, serum ferritin ≥ 100 µg/l or transferrin saturation ≥ 20% * confirmed negative anti-epo antibody assay from sample taken at screening visit -4 exclusion criteria: * systemic cyclosporine * history of prca or aplastic anemia * history of anti-epo antibodies * uncontrolled hypertension

Keywords: treatment associated with cri
tandem high dose chemotherapy with 131i-mibg treatment in high risk neuroblastoma

Conditions: High Risk Neuroblastoma

Summary: the purpose of this study is to evaluate the efficacy and toxicity of tandem hdct/asct including high-dose 131i-metaiodobenzylguanidine (mibg) treatment. in the present study, a single arm trial of tandem hdct/asct will be carried out.

although the outcome of high-risk neuroblastoma has improved after the introduction of hdct/asct, the outcome was still unsatisfactory with 30-40% of survival. we previously reported the results of a single arm prospective trial (smc nb-2004 study) using tandem hdct/auto-sct for high-risk neuroblastoma. in the nb-2004 trial, total body irradiation (tbi) was incorporated in second transplantation. survival rates were very encouraging; however, short- and long-term toxicities associated with tandem hdct/auto-sct, particularly tbi, were also very significant. for this reason, we designed a new prospective trial (smc nb-2009 study), in which only tbi in the second hdct/auto-sct of nb-2004 study was substituted with high-dose 131i-mibg treatment in order to reduce short- and long-term toxicities without jeopardizing survival rate.

Eligibility criteria:
inclusion criteria: * patients with high-risk neuroblastoma exclusion criteria: * patients with progressive disease before high-dose chemotherapy * patients whose parents want to stop or change the planned treatment * patients with organ toxicities of nci grade \>2 before high-dose chemotherapy
techniques to reduce the severity and frequency of emergent reactions

Conditions: Analgesia

Summary: the objectives of this study are first to determine if the power of suggestion will decrease the frequency and severity of emergence reactions after procedural sedation and analgesia with ketamine in the setting of the emergency department. second, to determine if people dream about what they were thinking about when they were induced with ketamine.

the proposed research will be single blinded (patient) randomized controlled trial with a retrospective component to test the hypothesis that the power of suggestion will reduce the frequency and severity of emergence reactions, even in the setting of the emergency department. the study will be conducted in the emergency department at christu spohn shoreline hospital. christus spohn shore hospital is the region's primary acute care center. it houses the chest pain, stroke, and cancer centers of christus spohn, and the only level ii trauma center in south texas. it is a major teaching affiliate of texas a\&m medical school, and serves an inner-city population.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age * required need for procedural sedation and analgesia exclusion criteria: * age\< 18 * hypertension * raised intracranial pressure * major psychological disorders * procedures involving laryngel manipulations * history of laryngeal sapsm history of adverse reactions to ketamine